Early Salvage Therapy for Patients With Advanced Features for Biochemical Relapse After Radical Prostatectomy for Localized Prostate Carcinoma In Correlation With Supposed Molecular-genetic Parameters of Higher Aggressiveness
Early Salvage Therapy for Patients With Advanced Features for Biochemical Relapse After Radical Prostatectomy for Localized Prostate Carcinoma In Correlation With Supposed Molecular-genetic Parameters of Higher Aggressiveness
The primary objective of the trial is to compare the impact and safety of delayed salvage therapy (dSRT, i.e., SRT initiated at PSA values of 0.4-0.5 ng/ml) to those of early salvage therapy (eSRT, i.e., at PSA levels of 0.2 ng/ml) in patients with biochemical relapse after radical prostatectomy.
The secondary objective of the trial is to perform analysis of the subgroups of patients to determine which patients are most likely to benefit from dSRT
Exploratory objective of the trial is to determine whether selected molecular genetic parameters (172 candidate genes and molecular alterations) and known clinical parameters can be used to identify potential predictors of worse prognosis in patients with known risk factors for relapse after radical prostatectomy, thereby augmenting and refining patient stratification, optimizing their therapy, and clarifying the proper timing of multimodal therapy
Inclusion Criteria:
> 18 years of age
Pathologically confirmed invasive prostate carcinoma with minimal 1 risk factor (RF) after radical prostatectomy (RP)
Patient refuses the adjuvant therapy after normalization of urinary function within 6 month after RP
Signed informed consent to participate in the study and (where necessary) consent to participate in the translational part of the research (not a requirement)
ECOG 0 - 1
pT2 and minimal 1 risk factor (RF):
pT3a /pT3b with or without one RF
No evidence of suspicious pelvic lymph nodes by initial diagnostic: cN0 and/or pN0
No evidence of suspicious distant metastases by initial diagnostic: M0
Patient with decline of PSA level to undetectable PSA levels (< 0,1 ng/ml) or around 0,2ng/ml and with another decreasing trends so that the PSA level decline within 12-24 weeks after RP to undetectable levels (< 0,1 ng/ml) and with renewed increase of PSA >0,2 ng/ml (BCR= biochemical relapse) without any clinical relapse on PSMA PET/CT
No hormonal therapy prior and /or after the radical prostatectomy
Patient suitable and fit for subsequent radiotherapy with high likelihood of good compliance to the follow-up
Exclusion Criteria:
sona.argalacsova@vfn.cz+420224962219
otakar.capoun@vfn.cz+420224962219